It's
been a whirlwind summer, full of great conferences like
ADA, Friends
for Life, AADE,
and an
excellent social media blogging summit
hosted by Roche.

It
was exciting to see so many of our d-friends in real life (and in one
place); especially since we often communicate by blog posts and
e-mails alone! The blogging summit had a wide agenda and hit on a
number of topics – but I was most intrigued by the focus to help
pharmaceutical companies engage in social media (and with bloggers)
the right way.

What
is the right way? First, bloggers encouraged Roche to be a part of
patients’ community. Our trust must be earned, they said, and it
can't be bought. We want companies to care about the impact their
product or service has on our lives & make sure they remember
that diabetes is 24/7: we don't get to leave diabetes after a 9-5
shift! It was pretty clear they realized that, in my view – we met
many people at Roche with diabetes and everyone certainly seemed
eager to understand it better.

Also,
we talked about the importance of acknowledging we can’t all be
perfect. It's important for people with diabetes to know that your
numbers won't always be a perfect 104, and that it's ok, because
we're human. It's normal to feel guilty about aspects of living with
diabetes, and it's important to acknowledge these feelings. There
were some complaints about having “104” on the boxes of meters,
etc – this is always a catch-22 to me, because of course if they
had 200 or 400, I think our doctors and educators wouldn’t really
like it.

One
thing the other blogs have mentioned is the high price of strips.
Since our work at Close Concerns focuses on the business of diabetes,
I thought I would weigh in on this. The revenues that blood glucose
monitoring companies have been taking in, on a per-strip basis, have
actually been declining for some time now, although the number of new
people with diabetes has meant that the overall market has increased
slightly the last couple of years – it grew 3% by our estimates in
2008 (hardly a banner year) and we believe it will decline this year
by about 5%. That’s due to a number of factors, but we think
managed care has been pushing blood glucose monitoring companies and
basically refusing to pay as much for strips as they did in the past.
At the same time, smaller companies from outside the US have entered
and began to compete on price, driving prices down. These companies
don’t offer as much in terms of quality and education, in our view.
So, although the companies do not report profitability, we can say
that revenues are declining and will decline further. It’s not to
say that the companies are going bankrupt – far from it, since
blood glucose monitoring revenues will still likely exceed $7.5
billion globally in 2009 – and may reach over $9 billion by 2014.
But from a growth perspective, this is far, far less growth than
insulin and oral drug companies are seeing. And, insulin pump
companies are growing much faster, if from a smaller base.

So
from my view, the fact that blood glucose monitoring companies are
profit-mongers couldn’t be further from the truth. Companies like
Roche as well as the other big blood glucose monitoring companies do
go way out of their way to make sure quality of the products is very
high, the education is well-funded, and the customer service is good.
Heck, at Roche, we even met someone from customer service (a
“card-carrying” type 1 himself!) who explained all the customer
service was done in Indianapolis itself – which I thought was a
positive, so that management could hear from them all the time about
what patients are thinking. I asked him whether the customer service
is getting more calls, just from people with diabetes and their
caregivers, looking for help, who may not have access to a doctor or
educator – that was true, in this economy, for sure. Anyway – I
personally found it a little uncomfortable hearing this company
accused of selling strips for over $1 that it made for $0.01 each –
while we didn’t get the exact answer on economics, our models
suggest that the companies are spending far, far more than that –
and while the average pharmacy cost for some strips exceeds $1, the
manufacturers actually do get far, far less than that (under 50% that
by our math, though those are only estimates).

I'm
thrilled we had an open dialogue with a pharma company about social
media and engaging patients. It's a step in the right direction –
and we're clearly walking before we learn to run. Big thanks to Roche
for hosting us and to Amy Tenderich and Manny Hernandez for giving
great talks that day – and to everyone there, who taught me so
much!

On August 4, CVS Caremark announced
the expansion of its MinuteClinic to treat chronic diseases including
diabetes, coronary heart disease, and hypertension
– very good news for patients in our view! MinuteClinic is
a part of CVS Caremark that provides walk-in healthcare
for the treatment of common illnesses. Currently MinuteClinic only offers
diabetes screening for $40, which consists of either a blood glucose
test or an A1c test. MinuteClinic does not allow co-pays to cover this
screening because it does not want the screening to replace an annual
examination. We look forward to seeing what
diabetes treatments MinuteClinic will provide, and are hopeful that
MinuteClinic’s efforts can help with earlier diagnosis and treatment
of diabetes. Really, where we think this could be the most helpful
is where patients could ask basic questions of the pharmacist about
various treatments – not, of course, as a
substitute for seeing their doctor or educator, but as a supplement.
We also would love to see CVS Caremark subsidize the cost of a diagnostic
a little more than they already are.

On August 6th, the Senate confirmed Judge Sonia Sotomayor as the 111th justice of the Supreme Court in a 68-31 vote. This makes her the first Hispanic, third woman, and first person with type 1 diabetes to serve on the court. While Sotomayor’s confirmation is no surprise--we considered her a shoo-in from the start--we are still overjoyed to have a Supreme Court Justice with diabetes. We hope Sotomayor will help raise awareness of diabetes and waylay many of the common misconceptions that the general public has about type 1 diabetes.

Read Jim Hirsch's article regarding Sotomayor in diaTribe 16 in which he explains how he got involved in the White House's efforts to handle the fallout. Click here to continue

We recently read an article in the New York Times about the accuracy of blood glucose monitors and whether the official accuracy standards for the devices need to be changed. This is an important issue, to be sure — millions of people with diabetes manage their diabetes treatment and dose their insulin based on the numbers from glucose monitors — but it’s also important not to let one article shake your faith in one of the most important tools we have in the struggle with diabetes.

The Times did a good job of presenting a “worst-case” scenario about the accuracy of meters, but in our view, the article overstated the problems and didn’t take into account how important meters are for good control.

Let’s talk about the numbers. Current standards from the International Organization for Standardization (IOS) require that nearly all (95%) of results from a glucose monitor have to be within 20% of the actual glucose value — as the Times reported. Later in the article, however, it cited a study of five common glucose monitors, saying that “results varied by as much as 32 percent.” What was not stated clearly in the article was that these five meters were never compared to the actual glucose value, only to each other — and that the 32% number was from the worst comparison between two meters (out of 10 possible combinations), and ONLY when the meters were used with old strips, and ONLY in the 70-100 mg/dL range. In contrast, the average variability between meters (with old or fresh strips, and across all glucose ranges) was about 9%, and the variability using only fresh strips was about 6%.

So what’s wrong with the Times article? While the accuracy of blood glucose meters is clearly a serious concern, it’s important to take the time to fully understand the data and to anticipate the reaction of people with diabetes upon learning that their meter is (potentially) off by 32%. We were alarmed that the results of Morgan DiSanto-Ranney’s high school science project could lead to her father testing less — as inaccurate as meters are, people with diabetes are certainly better off with them than without them. How can you figure out where to go with blood glucose if you don’t even know where you start? A recent literature review in JAMA evaluated large, recent trials showing that testing with a glucose monitor helps to improve control, which in turn reduces the complications of diabetes.

In addition, the Times missed out on the chance to give people with diabetes some really valuable information: for example, that meters are more precise when used with fresh test strips, that it’s very important to make sure patients test when their hands are clean (logical information that you would think would be unnecessary to convey, but studies have also shown problems on this front in “real life”), and that all meters are not created equal (one of the meters, dubbed meter “E”, seemed to perform worse than the others, and was one of the two meters in the comparison producing the 32% difference).

People with diabetes (and people in general) don’t have the time to follow up on every statistic in an article. We count on the media to represent issues fairly and consider the context of each article’s argument. In this regard, we believe the recent Times article on the accuracy of blood glucose monitoring fell short of the mark. Blood glucose monitoring is an important tool in diabetes management, and it will continue to be useful regardless of whether or not accuracy standards are changed.

From 1983 to 1993, the Diabetes Control and Complications Trial (DCCT) randomized 1,441 patients with type 1 diabetes to either conventional or intensive glycemic control. Conventional control meant taking one or two daily insulin injections, while intensive meant taking at least three daily injections of insulin and at least four blood glucose monitoring tests. The Epidemiology of Diabetes Interventions and Complications study (EDIC) was conducted as a follow-up to the DCCT and took place starting when DCCT ended; it is ongoing today.

A report published in the Archives of Internal Medicine on July 27, written by the DCCT Study Group and led by David M. Nathan, MD and collaborators analyzed data from the DCCT and EDIC trials (thus the name DCCT/EDIC) and showed dramatic improvements in outcomes for patients involved in the study compared with those who had been diagnosed just 10-20 years before. The outcomes from patients that have had diabetes for thirty (30!) years were presented and showed that patients in the intensive group had significantly fewer serious complications, namely proliferative retinopathy, nephropathy, and cardiovascular disease (CVD) compared to patients in the conventional group (when you see the word “significant” in scientific literature, you know it’s a big deal). "Now in the modern era, knowing how to use insulin more physiologically has led to really dramatically different outcomes,” said Dr. David Nathan of Mass General, a highly regarded endocrinologist and researcher and one of the study chairs for DCCT/EDIC.

This is hugely encouraging news and strong scientific evidence that the strides we’ve made in treating diabetes has made a huge difference. The data presented should also encourage patients with type 1 diabetes to strive for tight glycemic control – and today, we know it’s easier to do this with insulin pumps and CGM and therapies like rapid acting analogs and Symlin. While we know it can be hard in this economy to afford the latest and greatest therapies and technologies, this data may well be the evidence we need to get insurers to pay for more in the US. Although there are no conclusions yet for patients with type 2 diabetes, we will watch to see if the same conclusions can be made. A great day for people with diabetes – proving that our hard work in trying to stay in tight control does pay off!

On July 29th, the JDRF formally launched a very exciting on-line
Clinical Trials
Connection service. The service was launched to help patients with type
1 diabetes and their families better understand the clinical trials
landscape and inform them so that they can play an active role in the
search for better technologies, therapies, and ultimately, a cure. This
very cool (and free!) service provides descriptions of and access to
both
JDRF-funded and other clinical trials. After filling out a profile on
the site, the service will match you to trials that you might be
interested in.

The very cool part is that it's customized. So,
Clinical Trials Connection allows you to
search by trial location, compare trials side by side,
and create custom reports of trials to save and share with your family
and doctor and educator. This is a win-win-win in our view—it
should help patients by ending endless searching on clinicaltrials.gov,
it helps companies by finding people that are right for the trials
faster, helps doctors advise patients on trials that
are right for them, and facilitates the process so that the regulatory
process can be faster overall. Ultimately, we believe the impact could
be getting drugs and devices out to market quicker. We have just
started testing this out ourselves and urge all patients with type 1 to
enroll and try it out. The next step - let's convince another amazing
advocacy organization to recreate this tool for those with type 2
diabetes and with prediabetes!

One
of the team members was in New York City recently, and was startled to
look up in a mainstream restaurant (she only went into McDonald's for a
diet soda!) to see the calorie count listed on the menu. Like we've
discussed before, we're huge supporters of having correct nutritional
information out for consumers to see.

However,
menu labeling has previously only been mandated by law to large chains,
such as those with 20 or more units. One restaurant group claims that
this eliminates 75% of the industry, thus harming consumers.

Wait...fast
food restaurants on our side?! Maybe – we agree all restaurants should
have nutrition labels posted (carbs in addition to calorie counts, of
course!). However, it's a smooth move by this restaurant group who is
petitioning Congress to expand the potential legislation to require
more restaurants to post nutritional information. Like many big
industry efforts, their intentions may not really be for the good of
the consumer's health, but we're thrilled to see the discussion turn
back to the merits of nutrition labels & the importance of this
practice spreading nationwide!

On July 28th, 2009, the Senate Judiciary Committee voted 13 to six,
endorsing the Supreme Court nomination of Sonia Sotomayor, who has type
1 diabetes. All 12 Democrats on the committee voted for Judge
Sotomayor, while only Senator Lindsey Graham of South Carolina voted in
favor. This vote predicts a smooth path for her confirmation as the
first Latina member of the Supreme Court, and the first Justice with type 1 diabetes. Read the NYT article here

In our latest issue of diaTribe, Jim Hirsch explains how he got involved in the White House's efforts to handle the fallout. Click here to continue

And don't forget to sign up for the diaTribe CGM Giveaway.This month, we’re excited to be able to give away one $500 credit for DexCom merchandise! This contest is open to everyone, regardless of whether they’re diaTribe readers already, so help us spread the word about CGM by forwarding this post! Click here to enter the giveaway